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Impact on Functional Status in Older Adults Treated With L-Carnitine

Primary Purpose

Carnitine; Muscle, Functional Status, Old Age; Debility

Status
Unknown status
Phase
Phase 2
Locations
Uruguay
Study Type
Interventional
Intervention
L Carnitine
Supervised exercise
Placebos
Exercise at home
Sponsored by
Hospital de Clínicas Dr. Manuel Quintela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carnitine; Muscle focused on measuring carnitine, elderly, functional status

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who meet at least 2 criteria for the fragility phenotype of Linda Fried
  • Ability to comply with aerobic physical activity of moderate intensity and basic resistance.
  • Not depressed patients (Yesavage <5 in patients without previous depression or Hamilton <7 in patients in treatment for depression)
  • MMSE (Mini-Mental State Examination) greater than 24 points.
  • Independent or mildly dependent patients, Barthel> 95 points.
  • Patients without visual disturbances or with decreased visual acuity corrected.
  • No pain or with VAS (Visual analogue scale) <3/10.
  • Patients without nutritional risk, MNA (Mini Nutritional Assessment > 23.5 / 30 points) and BMI (Body Mass Index) > 23 kg / m2.

Exclusion Criteria:

  • Absolute contraindications for performing physical exercise: recent AMI or unstable angina, uncontrolled hypertension, acute HF and complete AV block.
  • Patients with osteoarticular pathology that limits their physical activity.
  • Previous neurological pathology (Stroke, Enf. Of Parkinson's).
  • Acute or chronic diseases decompensated or with lymphedema that makes difficult the accomplishment of the bioimpedanciometry.
  • Patients using orthopedic devices and prostheses or pacemakers that interfere with gait or impede the achievement of bioimpedanciometry.
  • BMI less than 23 and / or an involuntary weight loss of 3kg or more in the last 3 months.
  • Psychiatric disorders that hinder adherence to treatment.
  • Moderate to severe Chronic Renal Disease
  • Patient who does not agree to participate in the study.

Sites / Locations

  • Hospital de Clinicas Dr. Manuel Quintela

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

L Carnitine + Exercise at home

L Carnitine + supervised exercise

Placebos + supervised exercise

Arm Description

Patients who will receive L Carnitine, in liquid form, at a dosage of 2g per day, in a single intake, in addition to physical exercise advice at home for which a manual will be delivered in the consultation, for 12 weeks.

Patients receiving L Carnitine, in liquid form, at doses of 2g per day, in a single intake, in addition to a supervised physical exercise plan, for 12 weeks.

Patients receiving placebo and supervised exercise plan.

Outcomes

Primary Outcome Measures

Changes in elderly's function
Independence Scales for Activities of Daily Living
Gait speed
Gait speed measured after the intervention
Elderly's physical performance
Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).

Secondary Outcome Measures

Changes in the expression of fragility criteria
The Fragility criteria will be measured according to criteria promulgated and validated by Fried. The 5 original criteria will be used, but some measures to characterize the fragility will be adapted to the modifications of Avila-Funes.

Full Information

First Posted
May 31, 2017
Last Updated
June 6, 2017
Sponsor
Hospital de Clínicas Dr. Manuel Quintela
Collaborators
University of the Republic, Uruguay
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1. Study Identification

Unique Protocol Identification Number
NCT03180424
Brief Title
Impact on Functional Status in Older Adults Treated With L-Carnitine
Official Title
Impact on Functional Status in Older Adults Treated With L-Carnitine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Anticipated)
Study Completion Date
September 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clínicas Dr. Manuel Quintela
Collaborators
University of the Republic, Uruguay

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical exercise at home or supervised.
Detailed Description
The supplemental intake of L-carnitine improves the physical functioning of the pre-fragile and fragile elder of the community. Circulating L-carnitine levels increase after administration of the supplement. The impact on the function of L-carnitine in combination with physical exercise will be studied in a population of older adults in Montevideo. The sample will be divided into 3 groups, according to the intervention: Group 1: Patients who will receive L-Carnitine in addition to a manual to perform physical exercise at home. Group 2: Patients receiving L-Carnitine plus supervised exercise plan. Group 3: Patients receiving placebo and supervised exercise plan. All three groups will be evaluated for functional and anthropometric parameters: prior, during and after intervention. In addition, the dosage of L-carnitine and acetylcarnitine will be evaluated before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carnitine; Muscle, Functional Status, Old Age; Debility
Keywords
carnitine, elderly, functional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L Carnitine + Exercise at home
Arm Type
Active Comparator
Arm Description
Patients who will receive L Carnitine, in liquid form, at a dosage of 2g per day, in a single intake, in addition to physical exercise advice at home for which a manual will be delivered in the consultation, for 12 weeks.
Arm Title
L Carnitine + supervised exercise
Arm Type
Experimental
Arm Description
Patients receiving L Carnitine, in liquid form, at doses of 2g per day, in a single intake, in addition to a supervised physical exercise plan, for 12 weeks.
Arm Title
Placebos + supervised exercise
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo and supervised exercise plan.
Intervention Type
Drug
Intervention Name(s)
L Carnitine
Intervention Description
L Carnitine liquid, single daily dose of 2g orally.
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise
Intervention Description
Modified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Liquid substance, similar to the one containing L carnitine, in the same presentation
Intervention Type
Behavioral
Intervention Name(s)
Exercise at home
Intervention Description
A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision
Primary Outcome Measure Information:
Title
Changes in elderly's function
Description
Independence Scales for Activities of Daily Living
Time Frame
12 weeks
Title
Gait speed
Description
Gait speed measured after the intervention
Time Frame
12 weeks
Title
Elderly's physical performance
Description
Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in the expression of fragility criteria
Description
The Fragility criteria will be measured according to criteria promulgated and validated by Fried. The 5 original criteria will be used, but some measures to characterize the fragility will be adapted to the modifications of Avila-Funes.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Determine blood levels of L carnitine and acetylcarnitine
Description
Determine L-Carnitine and Acetylcarnitine levels in the study population before and after L carnitine supplementation.
Time Frame
12 weeks
Title
Determine levels of ammonia in blood
Description
Determine levels of ammonia in blood in the study population before and after L carnitine supplementation.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who meet at least 2 criteria for the fragility phenotype of Linda Fried Ability to comply with aerobic physical activity of moderate intensity and basic resistance. Not depressed patients (Yesavage <5 in patients without previous depression or Hamilton <7 in patients in treatment for depression) MMSE (Mini-Mental State Examination) greater than 24 points. Independent or mildly dependent patients, Barthel> 95 points. Patients without visual disturbances or with decreased visual acuity corrected. No pain or with VAS (Visual analogue scale) <3/10. Patients without nutritional risk, MNA (Mini Nutritional Assessment > 23.5 / 30 points) and BMI (Body Mass Index) > 23 kg / m2. Exclusion Criteria: Absolute contraindications for performing physical exercise: recent AMI or unstable angina, uncontrolled hypertension, acute HF and complete AV block. Patients with osteoarticular pathology that limits their physical activity. Previous neurological pathology (Stroke, Enf. Of Parkinson's). Acute or chronic diseases decompensated or with lymphedema that makes difficult the accomplishment of the bioimpedanciometry. Patients using orthopedic devices and prostheses or pacemakers that interfere with gait or impede the achievement of bioimpedanciometry. BMI less than 23 and / or an involuntary weight loss of 3kg or more in the last 3 months. Psychiatric disorders that hinder adherence to treatment. Moderate to severe Chronic Renal Disease Patient who does not agree to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Sgaravatti, MD
Organizational Affiliation
HospítalCDMQ
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas Dr. Manuel Quintela
City
Montevideo
ZIP/Postal Code
11600
Country
Uruguay

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact on Functional Status in Older Adults Treated With L-Carnitine

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